Testing Pembrolizumab with Bendamustine Hydrochloride for classical Hodgkin lymphoma

Exclusion

• −There is known severe (≥ Grade 3) hypersensitivity to pembrolizumab or bendamustine.
• −Has a known history of Human Immunodeficiency Virus (HIV), active tuberculosis (TB, Mycobacterium tuberculosis), or active hepatitis B or hepatitis C.
• −Patient receiving any other investigational agents, or on current treatment for RR HL, or has participated in a study of an investigational agent and has received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
• −Note: Subjects who have entered the follow-upFollow-upContinued check-ins after the treatment part is finished.Read more → phase of an investigational trial may participate as long as it has been 4 weeks since the last dose of the previous investigational agent.
• −Patient has had a prior monoclonal antibody within 4 weeks prior to first dose of therapy in the study, or who has not recovered from adverse eventsAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → due to agents administered more than 4 weeks earlier.
• −Patient has received prior treatment with bendamustine, either as monotherapy or as part of a combination regimen.
• −Patient has undergone prior allogeneic hematopoietic stem cell transplant.
• −Patient has another concurrent active malignancy (excluding non-melanoma skin cancer or carcinoma in situ of the cervix that has undergone potentially curative therapy), and must be disease-free and off treatment for \> 3 years.
• −Patient has known active central nervous system or meningeal disease.
• −Patients with active or past documented autoimmune disease that has required treatment in the past 2 years.
• −Patient is receiving systemic steroid therapy at a dose of \> 10 mg/day of prednisone (or equivalent) for 7 days prior to day 1 of study treatment.
• −Has an uncontrolled co-existing illness, including but not limited to: ongoing or active infection requiring systemic therapy; systemic congestive heart failure Class III or IV by NYHA criteria; unstable angina pectoris or cardiac arrhythmia; in patients status post allogeneic transplantation uncontrolled GVHD.
• −Patient has a history of (non-infectious) pneumonitis that has required steroid treatment, or concurrent active pneumonitis.
• −Patient has received a live vaccine within 30 days prior to first dose of study drugs.
• −Patient is eligible for autologous or allogeneic stem cell transplant, unless patient has declined this, therefore rendering themselves ineligible for stem cell transplantation.
• −Patient is pregnant, or nursing, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visitScreeningThe checks done before joining, to see whether a study fits.Read more → through 120 days after the last dose of pembrolizumab and/or bendamustine.
• −Patient is receiving any other, non-investigational, chemotherapy, radiotherapy, small molecule, or biologic agent within 4 weeks of the first dose of treatment, or who has not recovered (i.e., ≤Grade 1 or to baselineBaselineYour starting measurements, taken before treatment begins.Read more →) from AEs due to a previously administered agent.
• −Patient has received pembrolizumab, or another anti-PD1, or anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4, or anti-OX-40 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways, with disease progression whilst on therapy, or within 3 months of completion of this line of therapy, without intervening systemic therapy (including chemotherapy, antibody drug conjugates or other targeted agents).